The FDA recently approved a ‘two-fer’…. yep, TWO identical biosimilars with the approval of Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz) from Sandoz, Inc. They are the same formulations, and both received the coveted interchangeable designation. They are the first interchangeable biosimilars for RANKL inhibitors. Both therapies are available for subcutaneous administration. 

Jubbonti is indicated for the following (which are also currently approved for Prolia.)

• postmenopausal women with osteoporosis at high risk for fracture;
• increasing bone mass in men with osteoporosis at high risk for fracture;
• glucocorticoid-induced osteoporosis in men and women at high risk for fracture;
• increasing bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer; and
• increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Wyost is indicated for the following (which are also currently approved for Xgeva.)

• prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors;
• treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and
• treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

CLICK HERE to access prescribing information for both therapies.

Sandoz has yet to confirm pricing. 

Similarly, distribution details for either/both therapies have not been disclosed.

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the early press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are four LD deals that have been publicly confirmed subsequent to their approvals.

ONCO360 to distribute Voydea

Onco360 has been selected as a national pharmacy partner by Alexion Pharmaceuticals for Voydeya (danicopan) as a first class oral, Factor D inhibitor for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in combination with C5 inhibitor, Ultomiris (ravulizumab) or Soliris (eculizumab) for patients that experience clinically significant extravascular hemolysis (EVH).1 Voydeya® is an oral, Factor D inhibitor that acts in the alternative complement pathway of the immune system, providing control of red blood cell destruction within and outside the blood vessels.

ONCO360 to distribute Ojemda

Onco360 has been selected as a pharmacy partner by Day One Biopharmaceuticals for Ojemda (tovorafenib), which is now FDA approved for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

Orsini Specialty Pharmacy to Dispense Yargesa

Orsini Specialty Pharmacy has been selected by Edenbridge Pharmaceuticals as the preferred specialty pharmacy partner for the distribution of Yargesa (miglustat) capsules, 100mg. YARGESA is a glucosylceramide synthase inhibitor indicated for the treatment of adult patients with Type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option.

PANTHERx Rare to distribute Yargesa

PANTHERx Rare announced that it was selected by Edenbridge Pharmaceuticals for the distribution of Yargesa (miglustat) capsules, the first oral treatment option for adults with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option.

The FDA recently approved yet another – first in class -cellular therapy, Amtagvi (lifileucel) from Iovance Biotherapeutics Inc., indicated for the treatment of adult patients with a type of skin cancer (melanoma) that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies.

Exposure to ultraviolet light is the leading cause of Melanoma, a form of skin.  Melanomas represent approximately 1% of all skin cancers yet are related to a significant number of cancer-related deaths as they metastasize. 

Amtagvi is a tumor-derived autologous T cell immunotherapy composed of a patient’s own T cells. Tumor tissue from the patient is surgically removed and their T cells are separated from the sample. The resulting therapy is then infused in the patient as a single dose. This is the first FDA-approved tumor-derived T cell immunotherapy.

Amtagvi was approved with a Boxed Warning due to prolonged severe low blood count, severe infection, cardiac disorder, respiratory or renal function failure. 

CLICK HERE for prescribing information

The company confirmed that Amtagvi will carry a list price of $515,000.

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FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

CLICK HERE to read the full article

It is not often that I see a report of an event that is so extraordinary that it is jaw dropping. A report that BioPlus Specialty Pharmacy experienced a data breach in 2021 which, in itself, would not typically be extraordinary. However, the settlement imposed on BioPlus was a WHOPPING $2.2 million! That is the jaw dropping part.

We’ve often written about similar data breaches as warning signs for other specialty pharmacies to learn from and take actions that, which may be costly to implement but are cheap in the long run should something ‘hit the fan’.

In this case, the ‘fan’ cost BioPlus a tremendous amount  of cash. The article below mentions that the data breach exposed sensitive patient information of approximately 350,000 individuals. The amount of the fine is likely influenced by the size of the breach.

The yet unanswered question is….. “What’s Next?”Data security is already well established and most specialty pharmacies have already expended a lot of effort to build up their data firewalls and overall security. Will more regulation prevent future data breaches? Probably not…… given the ingenuity of those that will go anywhere at any time to get data either for ‘fun’ or profit. 

In a landmark settlement, BioPlus Specialty Pharmacy compensates for a significant data breach with $2.2 million, setting precedents for data privacy.

CLICK here to read the full article

……..catching up on FDA approvals

The FDA recently approved a new form of Eohilia (budesonide oral suspension) from Takeda , the first and only FDA-approved oral therapy for patients 11 years and older with eosinophilic esophagitis (EoE). Budesonide was first approved by the FDA under the brand name Pulmicort in 1997 as an oral inhalation formulation for the treatment of asthma.

EoE is a chronic disease that can significantly impact patients causing esophageal inflammation and intermittent symptoms of choking and difficult or painful swallowing.  The largest study in the U.S. found the prevalence of EoE to be 57/100,000, or approximately 152,000 cases.

Eohilia is given over a 12-week course in single-dose 2 mg/10 ml stick packs, taken twice daily. It has a wholesale acquisition cost of $1,875 per month.  Eohilia  will compete with Dupixent which costs around $3,800 for two prefilled pens, which are taken either once a week or once every other week for EoE. Eohilia is supplied in a carton containing 60 single-dose stick packs.

Takeda did not disclose distribution details. As Eohilia is limited to 12 weeks of treatment and has a relatively low cost compared to most specialty pharmacy therapies, it would not be surprising to see this therapy available through open access.

Click here for prescribing information

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FDA Approves Takeda’s EOHILIA (budesonide oral suspension), the First and Only Oral Treatment in the U.S. for Eosinophilic Esophagitis (EoE)

— 12 Weeks of Treatment with EOHILIA May Address Significant Unmet Needs of Patients 11 Years of Age and Older

— EoE Is a Chronic Disease That Can Significantly Impact Patients, with Esophageal Inflammation and Intermittent Symptoms of Choking and Difficult or Painful Swallowing

Click here to read the full article

……..catching up on FDA Approvals

The FDA recently approved a new infused therapy, Avzivi (bevacizumab-tnjn) from Bio-Thera Solutions, as a biosimilar to AVASTIN (bevacizumab). It did not receive an interchangeable designation.

Avzivi is indicated for the treatment of (refer to prescribing information for full indication):

• Metastatic colorectal cancer, in combination 
• Metastatic colorectal cancer, in combination 
• Non-squamous non-small cell lung cancer, in combination 
• Recurrent glioblastoma in adults
• Metastatic renal cell carcinoma in combination 
• Cervical cancer, in combination 
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination.

CLICK HERE to access prescribing information

Four biosimilar versions of Avastin were previously approved: 

• Mvasi (bevacizumab-awwb), 
• Zirabev (bevacizumab-bvzr), 
• Alymsys (bevacizumab-maly), and 
• Vegzelma (bevacizumab-adcd).

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FDA Approves Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin

• Avzivi (BAT1706) is Bio-Thera Solutions’ second FDA approved product in the United States
• Avzivi® is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States

CLICK HERE to read the full press release

The National Association of Specialty Pharmacy (NASP) recently released the results of a patient satisfaction survey of specialty pharmacies. The results are worth evaluating…… closely. Ultimately, satisfaction will influence patient preferences as to the type of specialty pharmacy they will prefer to use in the future.

The survey included 17,477 customers at 35 participating specialty pharmacies.

Here are the key findings… (the sample size is a bit small but is large wnough to ponder the findings)

• Academic medical center specialty pharmacies (13) scored highest—an average of 93.7% 
• Non-academic health-system specialty pharmacies (12) —92.8% 
• Independent specialty pharmacies (10) slid back to third place —89.2%.

Scores increased for all specialty pharmacies across the board from 2021 to 2022 in five key areas: 

• communication with the pharmacy team; 
• pharmacy’s ability to return calls in a timely manner;
• patient knowledge of their health conditions; 
• timeliness of prescription deliveries; and 
• keeping patients informed of their prescription status.

Here is where it gets interesting…. especially if you are at an independent specialty pharmacy. The survey also calculated Net Promoter Scores (NPSs), a person’s likelihood of recommending the pharmacy to family and friends.

• Academic specialty pharmacies had an 84.5 NPS
• Health-system pharmacies chipped in at 81.6 
• But…… Independent pharmacies only garnered a measly rate of 69.2….. ouch!

Independent specialty pharmacies should look in the mirror to see why hospital owned / operated SPs are doing much better on the NPS scale. These SPs are looking to drive as many patients into their column as possible. Now would be the time for independent SPs to seriously relook at patient satisfaction and think of things that will positively impact future contacts….. and not rest on past laurels.

Can’t you see I’m on a losing streak?

I can’t get no, oh, no, no, no, satisfaction…. hey, hey, hey

…………….the Rolling Stones seem to have seen the light

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The Key Drivers of Specialty Pharmacy Customer Satisfaction

Communication, trust cited in NASP survey

CLICK HERE to read the full article

…… catching up o FDA approvals

The FDA has approved a new specialty topical gel, Filsuvez (birch triterpenes) from Chiesi Farmaceutici S.p.A. Parma, indicated for the treatment of the rare, devastating skin disease epidermolysis bullosa (EB).

EB is a genetic, connective tissue disease that causes the skin to become fragile and blister. The condition can worsen to be life-threatening including the development of aggressive squamous cell carcinomas and infections.

The overall incidence and prevalence of EB are 19.6 and 11.07 cases per million live births, respectively. The incidence and prevalence of junctional epidermolysis bullosa are estimated at 2.68 and 0.49 cases per one million live births.

Chiesi has not published acquisition pricing. However, they have confirmed that PANTHER Rx Rare was selected as a limited distribution partner for Filsuvez.

CLICK HERE for prescribing information

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After Amryt buyout, Chiesi scores with FDA nod for rare skin disease treatment Filsuvez

The FDA’s approval of rare skin disease drug Filsuvez gives Chiesi Global Rare Diseases its third nod for a new drug from the U.S. regulator this year. (Chiesi)

Seven months after Krystal Biotech became the first company to gain FDA approval to treat, Chiesi Farmaceutici has followed suit.

CLICK HERE to read the full article

We’ve often written about the battle being fought around site-of-care. As we’ve suggested previously, it comes down to one word….. MONEY.

Payers have been turning up the flame under the pot in which the battle is being fought. They are increasingly looking to move in more aggressive ways to redirect patinets away from comparatively very expensive hospital outpatient departments and into alternate site of care.

The article below lays out one new strategy by a large payer, Blue Cross Blue Shield of Michigan, to redirect their members to lower cost sites of care. A new policy that went into effect few weeks ago included a targeted list of drugs “may be covered only when administered at the following sites of care:

• Doctor’s or other health care provider’s office
• The member’s home, administered by a home infusion therapy provider
• Ambulatory infusion center.”

Here are the targeted therapies…

• Bavencio
• Imfinzi
• Imjudo
• Jemperli
• Keytruda
• Libtayo
• Opdivo
• Opdualag
• Tecentriq
• Yervoy
• Zynyz

We will not be surprised to see other payers follow this strategy….. especially as each newly infused therapy appears break new records for price.

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Additional drugs to have site-of-care requirements for some Blue Cross commercial members, starting March 15

CLICK HERE to read the press release

……………catching up on FDA approvals

The FDA approved a new ORAL therapy, Fabhalta (iptacopan) from Novartis, the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).  Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system. It provides comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]). 

PNH is characterized by hemolysis, bone marrow failure, and thrombosis in varying combinations and levels of severity.  Up to 88% of patients on legacy treatment may have persistent anemia with over one-third of those patients requiring blood transfusions at least once per year. Nearly all patients treated with Fabhalta did not require blood transfusions.

Was approved with a Black Box Warning — FABHALTA increases the risk of serious and life-threatening infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B.

The wholesale acquisition cost for Fabhalta is $26,900 for one month supply.

Since its approval, Novartis has confirmed that Fabhalta is being dispensed by at least two specialty pharmacies, Onco360 and Biologics by McKesson.

CLICK HERE to access prescribing information

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Novartis receives FDA approval for Fabhalta (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH

CLICK HERE to read the full press release